Alcon Custom Ophthalmic Surgical Procedure Packs — Class II medical device recall Z-1328-2021
Terminated recall by Alcon Research, LLC, reported 2021-04-07, distributed nationwide. Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
| Recall number | Z-1328-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, LLC, Houston, TX, United States |
| Recall initiated | 2021-02-02 |
| Classified | 2021-04-01 |
| Reported by FDA | 2021-04-07 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, MX, MY, NZ, TH |
| Quantity | 249,853 custom |
| Reason classes | microbial contamination |
| Pathogens | mold |
| Lot numbers | 0012-61, 0017-68, 0017-69, 0091-68, 0091-69, 0147-62, 0148-63, 0188-76, 0204-58, 0234-66, 0235-74, 0316-66, 0365-74, 0437-38, 0472-56, 0486-69, 0540-73, 0540-74, 0557-75, 0562-64, 0587-88, 0607-57, 0613-80, 0630-68, 0633-57, 0650-75, 0680-72, 0720-71, 0721-59, 0721-60, 0773-66, 0774-65, 0800-70, 0802-62, 0835-59, 0847-86, 0849-75, 0888-68, 0933-71, 0938-57 and 460 more |
Product
Alcon Custom Ophthalmic Surgical Procedure Packs
Reason for recall
Reports have been received concerning mold found on gowns included in custom ophthalmic surgery packages.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1328-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.